Intended use:

For in vitro diagnostic use. The RIDASCREEN® Helicobacter test is an enzyme immunoassay for the quantitative determination of IgA or IgG antibodies against Helicobacter pylori in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Helicobacter or for clarifying the immune status.

General information:

The diagnostic strategies for H. pylori can be divided into invasive and non-invasive methods. With the invasive gastroscopy a histological investigation of the derived biopsy material is combined with the detection of organism’s urease activity in the biopsy material. But, the biopsy can lead to false negative results, since material can be removed from places of the stomach where Helicobacter pylori has not colonized. With the identification of serum antibodies – whereby IgG is of main interest and IgA sometimes gives additional information – or the detection of H. pylori antigen in stool the non-invasive diagnosis by enzyme immunoassay gains increasing importance in view of its advantages for the patients. Herewith, the enzyme immunoassay is distinguished by its easy handling as a screening method. Additionally, the line blot has the advantage that it differentiates between type I and II H. pylori. Herewith, an analysis of the different Helicobacter pylori types with their clinical significance is made possible for epidemiological investigations.

Test principle:

Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second incubation step by using enzyme-labelled anti-human antibodies (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.

Please also pay attention to our line blots for antibody detection against H. pylori (Art. No.: LB2313 and LB2323) and to our ELISA for H. pylori antigen detection in stool specimens (Art. No.: C2301).

Art. No. K23**
Test format Article no. K2311
Helicobacter IgA (96 determinations)

Article no. K2321
Helicobacter IgG (96 determinations)

Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)
Incubation time 3 x 30 min at 37 ºC
Sensitivity 100.0% (IgA)
100.0% (IgG)
Specificity 94.7% (IgA)
100.0% (IgG)
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